Method and apparatus for vacuum-formed dental appliance

ABSTRACT

An appliance and methods are described that include embodiments of a mandibular advancement or positioning device which can use elastic bands to pull the jaw forward. The appliance has an upper plastic tray conforming to the patient&#39;s upper teeth and including a set of retention hooks coupled to the upper plastic tray via being encased in plastic, one on the right and one on the left anterior buccal portion of an upper plastic base. The appliance also has a lower plastic tray conforming to the patient&#39;s lower teeth and has a set of bite pads integrated with a second set of plastic retention hooks encased in plastic extending outwardly from the teeth. The appliance includes the upper and lower plastic trays and specially formed elastic bands of a plurality of lengths and strengths replaceably attached to the retention hooks on both sides of the trays to pull the mandible forward for treatment.

CROSS REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 13/520,520, now U.S. Pat. No. 8,882,497, titled “METHOD ANDAPPARATUS FOR VACUUM-FORMED DENTAL APPLIANCE”, filed Jul. 3, 2012, whichis a national stage application under 35 U.S.C. 371 of InternationalApplication PCT/US2011/030367, titled “METHOD AND APPARATUS FORVACUUM-FORMED DENTAL APPLIANCE”, filed on Mar. 29, 2011, which claimsbenefit under 35 U.S.C. § 119(e) to U.S. provisional application61/318,662, titled “METHOD AND APPARATUS FOR VACUUM-FORMED DENTALAPPLIANCE” filed Mar. 29, 2010.

FIELD

This invention relates generally to oral appliances for preventing or atleast alleviating snoring and sleep apnea. At the present, there is noknown vacuum formed, non-invasive, inexpensive custom dentist-made sleepdisorder breathing appliance. Known trial sleep apnea appliances havebeen made of bulky boil & bite materials. More specifically, thisinvention relates to a dental office manufacturing method utilizingtechniques and machines in most dental offices to manufacture a trialremovable mandibular advancement appliance which can use elastic bandsto pull the jaw forward and bite pads to open the bite vertically. Inaddition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

SUMMARY

An appliance and methods are described that include embodiments of amandibular advancement or positioning device which can use elastic bandsto pull the jaw forward. The appliance has an upper plastic trayconforming to the patient's upper teeth and including a set of retentionhooks coupled to the upper plastic tray via being encased in plastic,one on the right and one on the left anterior buccal portion of an upperplastic base. The appliance also has a lower plastic tray conforming tothe patient's lower teeth and has a set of bite pads integrated with asecond set of plastic retention hooks encased in plastic extendingoutwardly from the teeth. The appliance includes the upper and lowerplastic trays and specially formed elastic bands of a plurality oflengths and strengths replaceably attached to the retention hooks onboth sides of the trays to pull the mandible forward for treatment. Anembodiment provides a method of making a trial dental appliance for apatient including temporarily attaching a first set of retention hooksto models of the patient's upper teeth; temporarily attaching a set ofbite pads integrated with a second set of retention hooks to the modelof the patient's lower teeth; vacuum forming sheets of plastic over themodels of the patent's upper and lower teeth with the temporarilyattached first set of retention hooks and the set of bite padsintegrated with the second set of retention hooks in a machine to formupper and lower plastic trays vacuum-formed to fit over the teeth of thepatient, the heat from the vacuum machine enabling the sheets of plasticto encase the temporarily attached first set of retention hooks and theset of bite pads integrated with the second set of retention hooks; andremoving the trays from the models with the incased parts, the removalof the trays detaching the first set of retention hooks and the set ofbite pads integrated with the second set of retention hooks from themodels to form the dental appliance to enable attachment of a pair ofelastic bands to be placed over the first and second sets of encasedretention hooks. In addition to the foregoing, other system aspects aredescribed in the claims, drawings, and text forming a part of thepresent disclosure.

An embodiment provides an oral appliance including upper and lower traysadapted to fit tightly but removably over the occlusal surfaces of theupper and lower teeth of a patient; a first set of retention hooksencased by the upper tray; a set of bite pads integrated with a secondset of retention hooks encased by the lower tray to form a bite plane onthe occlusal surface of both sides of the lower tray, each bite padhaving a bite surface which protrudes therefrom so as to engage theocclusal surfaces on the upper tray and thus maintain the occlusalsurfaces of the trays in predetermined spaced relation, when the traysare so fitted; and means to releasably attach the anterior and posteriorportions of both sides of each tray using the first set of retentionhooks and the second set of retention hooks to enable a lower jaw toadvance forwardly when the upper and lower trays are fitted over thepatient's teeth. In addition to the foregoing, other computer programproduct aspects are described in the claims, drawings, and text forminga part of the present disclosure.

The foregoing is a summary and thus contains, by necessity,simplifications, generalizations and omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is not intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processesdescribed herein, as defined by the claims, will become apparent in thedetailed description set forth herein.

BACKGROUND

It is well documented in the literature that an oral appliance thatopens the bite and moves the mandible forward will greatly reduce sleepapnea and snoring. It is also documented that these appliances arecapable of producing considerable discomfort to patients, unwantedmovement of their teeth, and/or temporomandibular joint pain as well asother problems.

A variety of trial oral appliances are available for preventing snoringand sleep apnea. Of these, all are removable, and most advance themandible, but, to our knowledge, none use elastic bands to move themandible forward. Heretofore all trial dental sleep appliances have beenmade of bulky “boil & bite” material. These appliances have not beeneffective and have not had patient acceptance or compliance. Theseuncomfortable devices have driven patients away from wanting to betreated by a custom oral appliance.

Also, several removable, oral snoring/apnea appliances are adjustable,pulling the jaw forward in different, set percentages of their maximummovement. However, no existing appliance known to us is totallyadjustable, both in amount of forward movement and vertical opening.Instead, temporary or permanent adjustments to appliances are made byeither placing spacers, turning screws, or by grinding away plastic orother material. These modifications change the amount of advancement;however, have locked the patient's jaw in one ridged spot causing TMJpain. Once modifications are made, however, they are permanent untilfurther modified by the doctor. In summary, appliances exist in whichthe amount of advancement may be changed, but the changes result in anew fixed position of the mandible many times creating pain anddiscomfort. Other appliances do not offer easily changed vertical orcaudal displacement of the mandible to increase the effectiveness of theappliance.

What is needed is a totally adjustable trial oral snoring/sleep apneaappliance which is effective, which has high patient acceptance, andwhich will not cause temporomandibular joint problems, unwanted toothmovement or soreness. This need is satisfied by the present invention.

The appliance of the present invention is to greatly reduce, oreliminate, sleep apnea and snoring, while alleviating temporomandibularjoint problems, unwanted tooth movement and soreness, with completeadjustability of the appliance both in the amount of forward movement ofthe lower jaw, and in the amount of vertical bite opening. Anotherobject is a mandibular advancement appliance with high patientacceptance, comfort, and treatment success. Another object is to makethe appliance in a single office visit using machines normally suppliedin a typical dentist's office.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the subject matter of the application can beobtained when the following detailed description of the disclosedembodiment is considered in conjunction with the following drawing, inwhich:

FIG. 1 illustrates a dental mold in accordance with an embodiment of thesubject matter of the present application.

FIG. 2 illustrates a dental mold with bite pads temporarily attachedthereon in accordance with an embodiment of the subject matter of thepresent application. embodiment of the subject matter of the presentapplication.

FIG. 3 illustrates a top view of a dental appliance in accordance withan embodiment of the subject matter of the present application.

FIG. 4 illustrates a vacuum forming device forming plastic to a dentalmold in accordance with an embodiment of the subject matter of thepresent application.

FIGS. 5 and 6 illustrate a retention hook encased in plastic as part ofa dental appliance in accordance with an embodiment of the subjectmatter of the present application.

FIG. 7 illustrates a dental application in accordance with an embodimentof the subject matter of the present application.

The use of the same symbols in different drawings typically indicatessimilar or identical items.

DETAILED DESCRIPTION

Embodiments herein relate to methods and systems for manufacturing anoral appliance that requires only a single office visit.

During the office visit, a patient can befitted for an oral appliance byfirst obtaining an upper (maxillary) and lower (mandibular) impressionof the teeth and supporting soft tissue including the upper hard palate.This impression must be extremely accurate to avoid tooth soreness,and/or movement when the appliance is placed in the patient's mouth. Theimpression is taken by: (1) having the patient rinse with apre-impression mouth wash to eliminate any saliva distortion; and (2)pouring the impressions immediately to avoid distortion using a hard labstone.

Referring now to FIG. 1, the impressions are used to make a model of thepatient's teeth 110 and 112. The model 110 and 112 are then altered bytemporarily attaching a first set of retention hooks to the model of thepatient's upper teeth. The attachment can be by dental wax, glue, suchas a polymer glue or Super Glue.

The retention hooks are placed between the cuspid and first bicuspid onthe upper model. Next, with the upper models held in centric occlusionwith the lower model, a measuring device can be placed over the upperretention hook and with a fine point “Sharpie”™ pen to scribe a mark onthe lower model 23, 25, or 27 mm depending on the size of the patient'sdental arch. Referring to FIG. 1, marks 120 and 130 illustrate possiblelocations for marking models 110 and 112. In one embodiment, a kitincluding an appropriate measuring device can be included to enableproper placement of the marks.

Referring to FIG. 2, in one embodiment, lower bite pads 220 aretemporarily attached. The lower bite pads 220 can be integrated with asecond set of retention hooks 230. A scribed line on the lower model inone embodiment can be under the center of the second set of retentionhooks and the top portion of the bite pad and should be level with thebite pad on the opposite side of an arch.

In one embodiment, the displacement between the corresponding retentionhook of the second set of retention hooks and the correspondingretention hook of the first set of retention hooks can be 23, 25 or 27millimeters displaced as measured from center to center. Referring toFIG. 3, a view 300 of the appliance, including both upper and lowertrays, illustrates line 320, as a measurement between retention hooks onone side of the trays.

Next, in a machine typically seen in a dentist's office, such as athermo-plastic machine 400 shown in FIG. 4. The dentist can place sheetsof plastic 410 in the machine so that upon heating and applying avacuum, the sheets are pulled down over the model 420 of the patent'supper and lower teeth, one at a time, with the temporarily attachedfirst set of retention hooks and the set of bite pads integrated withthe second set of retention hooks. The machine can operate on the upperand lower teeth models separately, as will be appreciated by thoseskilled in the art.

The heated plastic 410 encases, via vacuum sealing, each of the upperand lower teeth models and the retention hooks and bite pads to formupper and lower plastic trays adapted to fit over the teeth of thepatient with the retention hooks and bite pads encased by the plastic.

In one embodiment, the bite pads can be placed to create an 8 mmanterior vertical opening between the upper and lower teeth to assistwith treating sleep apnea. Information can be obtained from the patientas to any pressures on the teeth or gingiva.

Also, in an embodiment, the appliance, including both upper and lowertrays, can be checked for comfort and evenness of opening from side toside with the patient. If pressures are felt by the patient on any toothor any area of the gingiva, then these areas can be carefully relieved.

Some reasons for pressure on the teeth or gums include the following:(1) an inaccurate impression; and/or (2) a warped model. Advantageously,in a single office visit, there is generally no concern of interveningtooth movement or dental work since the impression can be obtained andthe appliance manufactured on a same visit.

The machine 400 can be a thermo plastic machine, a vacuum-formingmachine or the like. For example, the machine 400 can be configured toheat the sheets of plastic and vacuum seal the models of the upper andlower teeth to encase the temporarily attached first set of retentionhooks, both right and left, and the set of bite pads integrated with thesecond set of retention hooks, both right and left as shown in FIG. 1.

After the plastic is vacuum sealed over the models, bite pads andretention hooks, the trays formed by the plastic are removed from themodels. Removal can be accomplished by cutting with scissors, a dentalburr, or a knife or other sharp implement.

In an embodiment, the removal of the trays from the models causes thetemporarily attached retention hooks and bite pads to be released fromthe models and become integrated with the plastic trays created by thevacuum sealing process. Referring to FIG. 5, to insure proper releasefrom the models, in one embodiment, the retention hooks are formed suchthat each retention hook includes an edge 510 that enables the plastic520 to seal around each retention hook to prevent the retention hooksfrom remaining attached to the respective model. In an embodiment, edge510 can include a groove or other shape that enables the retention hooksto become secured by the plastic around the circumference of eachretention hook to insure detaching of each retention hook from eachmodel.

Likewise, referring to FIG. 6, retention hook includes an edge 610 toenable plastic 620 to encase the hook and bite pad combination toprevent the retention hook and bite pad combination from remainingattached to a model. Edge 610 can be a groove or other shape thatinsures detachment from the model. Likewise, each bite pad can beconfigured with a groove or the like to assist removing of the bite padfrom the model.

Referring to FIG. 7, shown is an embodiment of the final appliance 700including encased first set of retention hooks 720 and set of bite pads730 integrated with the second set of retention hooks from the models toform a dental appliance 700 including both upper and lower trays.

FIG. 7 illustrates an embodiment including elastic bands 750 that couplethe first tray and the second tray to enable the appliance 700 to treatsleep apnea. The vacuum forming over the retention hooks encases theretention hooks and the bite pads such that upon cooling, the applianceincludes the retention hooks such that elastic bands 750 can be securelyplaced over the retention hooks during treatment.

The appliance 700 created with plastic covering the retention hooks andbite pads enables attachment of a pair of elastic bands 750 to beremovably placed over the first and second sets of encased retentionhooks to create a sleep apnea appliance, as shown in FIG. 7.

In one embodiment, the bite pads can be configured with one or moregrooves and/or edges such that the plastic covering the retention hooksand bite pads does not prevent “snap on” bite pad extensions from beingplaced on each of bite pads. Thus, as shown in FIG. 7, bite pads 730 caninclude bite pad extensions that enable the bite pads to increase thevertical displacement between the upper and lower trays. In oneembodiment, at least three different snap on bite pad extensions ofvarious thicknesses can be configured to snap over the encased bite padson the bottom tray to increase the amount of vertical displacement ofthe lower jaw when the appliance is worn.

Thus, if successful treatment for sleep apnea is not obtained with thevertical displacement rendered by the plastic-encased bite pads of thelower jaw, adequate vertical displacement can be obtained by temporarilysnapping one of a plurality of thicknesses of “snap on bite padextensions” over the encased bite pads.

In one embodiment, the choice of size of bite pad extension can be inaccordance with a determined patient comfort including much air flow andefficacy.

In one embodiment, a bite pad extension can be permanently secured via athin mix of orthodontic acrylic or a thin mix of light cure material. Topermanently secure the bite pad extension, a prepared mix can be placedinside a dry “snap on bite pad extension”. After firmly securing theextension over a dry encased bite pads right & left, mix material canescape through two holes in the bit pad extension to enable properseating. The lower appliance with extensions on the bite pads can becured as is known for acrylic material or cured with a light gun.

After bite pad extensions, if necessary, are attached over the encasedbite pads to add vertical opening, a patient using the appliance can befitted with a different appliance with known advancement and verticalopening for successful treatment via a permanent appliance.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from this subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of this subject matter describedherein. Furthermore, it is to be understood that the invention is solelydefined by the appended claims. It will be understood by those withinthe art that, in general, terms used herein, and especially in theappended claims (e.g., bodies of the appended claims) are generallyintended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should not be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to inventions containing only one such recitation, even whenthe same claim includes the introductory phrases “one or more” or “atleast one” and indefinite articles such as “a” or “an” (e.g., “a” and/or“an” should typically be interpreted to mean “at least one” or “one ormore”); the same holds true for the use of definite articles used tointroduce claim recitations. In addition, even if a specific number ofan introduced claim recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). In those instances where a conventionanalogous to “at least one of A, B, or C, etc.” is used, in general sucha construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that any disjunctive word and/orphrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

The herein described aspects depict different components containedwithin, or connected with, different other components. It is to beunderstood that such depicted architectures are merely exemplary, andthat in fact many other architectures can be implemented which achievethe same functionality. In a conceptual sense, any arrangement ofcomponents to achieve the same functionality is effectively “associated”such that the desired functionality is achieved. Hence, any twocomponents herein combined to achieve a particular functionality can beseen as “associated with” each other such that the desired functionalityis achieved, irrespective of architectures or intermedical components.Likewise, any two components so associated can also be viewed as being“operably connected,” or “operably coupled,” to each other to achievethe desired functionality. Any two components capable of being soassociated can also be viewed as being “operably couplable” to eachother to achieve the desired functionality. Specific examples ofoperably couplable include but are not limited to physically mateableand/or physically interacting components and/or wirelessly interactableand/or wirelessly interacting components and/or logically interactableand/or logically interacting components.

While certain features of the described implementations have beenillustrated as disclosed herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the embodiments of the invention.

What is claimed is:
 1. An oral appliance comprising: an upper trayadapted to fit tightly but removably over one or more occlusal surfacesof upper teeth of a patient, the upper tray including a first set ofretention hooks encased by plastic of the upper tray; and a lower trayadapted to fit tightly but removable over one or more occlusal surfacesof teeth of the patient, the lower tray including a set of bite padsintegrated with a second set of retention hooks, the second set ofretention hooks and the set of bite pads encased by plastic of the lowertray, each bite pad of the set of bite pads having a bite surface whichprotrudes therefrom so as to engage one or more occlusal surfaces on theupper tray and thus maintain the one or more occlusal surfaces of theupper and lower trays in a predetermined spaced relation, when the upperand lower trays are fitted on the patient, wherein the set of bite padsintegrated with a second set of retention hooks encased by plastic ofthe lower tray are adapted to enable one or more extensions to beattached to each bite pad of the set of bite pads.
 2. The oral applianceof claim 1 further comprising: means to releasably attach an anteriorand a posterior portion of each tray by placing a pair of elastic bandsover the first set of retention hooks and the second set of retentionhooks to enable a lower jaw of the patient to advance forwardly when theupper and lower trays are fitted over teeth of the patient.
 3. The oralappliance of claim 2 wherein the pair of elastic bands is one of atleast three different lengths of elastic bands and at least twodifferent strengths.
 4. The oral appliance of claim 1 wherein the one ormore extensions include one of at least three thicknesses to increase anamount of vertical displacement of a lower jaw when the oral applianceis worn.
 5. The oral appliance of claim 1 wherein the one or moreextensions are permanently secured to each bite pad of the set of bitepads via one or more of a thin mix of orthodontic acrylic or a thin mixof light cure material.